Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model Recalled by LivaNova USA Inc Due to Firm identified a subset of its generators that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA Inc directly.
Affected Products
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
Quantity: 6 generators
Why Was This Recalled?
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
Where Was This Sold?
This product was distributed to 5 states: FL, GA, KS, MO, UT
About LivaNova USA Inc
LivaNova USA Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report